Merck: FDA reviewing pill form of antifungal drug

Wednesday, April 10, 2013

TRENTON — Merck & Co. said Wednesday that the Food and Drug Administration is reviewing its application to sell a pill form of its drug for preventing dangerous fungal infections in high-risk patients.

Noxafil, known chemically as posaconazole, is already sold in a liquid form, approved for patients aged 13 and older. It’s given to patients who have severely weakened immune systems that put them at high risk of infections from fungi including Aspergillus and Candida.

That includes cancer patients who have low levels of infection-fighting white blood cells due to chemotherapy, organ transplant patients with a life-threatening complication called graft-versus-host disease and patients who have received stem cell transplants.

“Invasive fungal infections are a significant cause of illness and death among severely immune-compromised patients,” Dr. Robin Isaacs, head of infectious disease clinical research at Merck Research Laboratories, said in a statement.

Merck, which is based in Whitehouse Station, N.J., is seeking U.S. approval to sell the pills as a once-a-day treatment, following an initial dose of two pills a day. In addition, the company has applied for approval to sell them in Europe, and it plans to seek approval from regulators in other countries.

In patient tests of the drug, a small number suffered liver complications, including liver failure and death. The most common side effects, reported in more than 30 percent of participants, were fever, diarrhea and nausea.

In addition, the drug is not recommended for people who are already taking a number of drugs, including immune-suppressing medicines, widely used statins for reducing cholesterol and blood pressure drugs called calcium channel blockers, as well as medicines for migraine headaches, Tourette’s syndrome and irregular heart rhythms.

The drug has not been tested for safety in patients under 13 years old.